av Fistula Patency Loss as a Cause of Fistula Failure and Hyperphosphatemia

October 3, 2022 updated by: Kerollos Refaat Labeeb, Assiut University

av Fistula Patency Loss as a Cause of Fistula Failure and Its Relation to Hyperphosphatemia in Chronic Hemodialysis Patients

Assessment of arteriovenous fistula patency loss which leads to av fistula failure and its relation to high serum phosphate level in chronic hemodialysis patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

End-stage renal disease is a chronic disease requiring treatment with dialysis or renal transplantation. Patients require an adequate vascular access for hemodialysis (HD). Autologous arteriovenous fistula (AVF) is gold standard to maintain vascular access for HD . Vascular access-related complications can lead to patient morbidity and reduction of patient quality of life.The complication rate related to permanent HD vascular access remains relatively high and access related problems are responsible for 50% of the hospitalization of dialysis patients. Secondary failures are not rare and in need of adequate attention and care. Once the AVF has been placed. It is recommended that serial monitoring of the AVF should be done for long term effective function. Delays in preventing complications may lead to AVF dysfunction. However, little is known about the factors determining long term prognosis of an AVF.

Primary patency (intervention-free access survival) was defined as the interval from time of access placement to any intervention designed to maintain or reestablish patency or to access thrombosis or the time of measurement of patency. Assisted primary patency (thrombosis-free access survival) was defined as the interval from time of access placement to access thrombosis or time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of a patent access. Secondary patency (access survival until abandonment) was defined as the interval from time of access placement to access abandonment or time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to reestablish the functionality of thrombosed access .

In patients having chronic renal failure (CRF), several changes occur in bone metabolism due to the development of secondary hyperparathyroidism. There are increased calcium and phosphate release from bones to the blood, causing the deposition of calcium and phosphate in the intima-media layer of arterial wall and eventuating vascular calcification in these patients. The deposition of these electrolytes increases the risk of cerebrovascular and coronary complications as well. Thus, a decrease in the quality of fistula occurs in these tracts utilized frequently at the arteriovenous fistula (AVF) operations.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

- adult patients more than 18 years old with end stage renal disease on regular hemodialysis using arteriovenous fistula

Description

Inclusion Criteria:

  • adult patients more than 18 years old with end stage renal disease on regular hemodialysis using arteriovenous fistula

Exclusion Criteria:

  • : patients less than 18 years, patients with peripheral artery diseases, access failure occurred within the first 2 months after fistula surgery, AVF failure was related to an infectious complication and patients with arteriovenous grafts.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
av fistula patency loss with hperphosphatemia
hemodialysis patients with av fistula patency loss by doppler ultrasound and hyperphosphatemia
Device: doppler ultrasound
doppler ultrasound on arteriovenous fistula in hemodialysis patients
av fistula patency loss with normal phosphate level
hemodialysis patients with av fistula patency loss by doppler ultrasound and normal phosphate level
Device: doppler ultrasound
doppler ultrasound on arteriovenous fistula in hemodialysis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of early av fistula patency loss
Time Frame: baseline
early measurement of av fistula patency loss using doppler ultrasound to decrease the fistula failure rate
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement if there is a relation between fistula patency loss and hyperphosphatemia
Time Frame: baseline
analysis if a high serum phosphate level leads to arteriovenous fistula patency loss
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • av fistula and phosphate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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